ENDS Toxicity / Carcinogenic: Difference between revisions

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=ENDS vs Smoking Tobacco, Heated Tobacco Product/Heat not Burn, or Nicotine Replacement Therapy=

=== 2024 [https://www.frontiersin.org/journals/chemistry/articles/10.3389/fchem.2024.1433626/full Analytical methods and experimental quality in studies targeting carbonyls in electronic cigarette aerosols] ===

* This review highlights the necessity to evaluate the quality of laboratory standards in testing EC emissions to achieve an objective assessment of the risk profile of ECs.

* Since the presence of carbonyl by-products in EC aerosol is concerning, it is important to evaluate the reliability of emission studies quantifying these compounds by verifying their compliance with the following criteria of experimental quality: authors must 1) supply sufficient information on the devices and experimental procedures to allow for potentially reproducing or replicating the experiments, 2) use of appropriate puffing protocols that approach consumer usage as best as possible, 3) use of appropriate analytical methods and 4) usage of blank samples to avoid false positive detection.

* However, the studies exhibited the following experimental flaws:

** Although only five of the 14 studies used blank samples, alternative validation methods have been employed.

** six studies failed the replicability condition by not disclosing sufficient information on the devices and experimental procedures.

* The issues listed above are serious methodological flaws that occur also in many emission studies.

* TL/DR There is a lot that needs to be improved to ensure studies accurately reflect real usage conditions.

* Sussman RA, Sipala FM, Ronsisvalle S and Soulet S, Front. Chem., 09 August 2024 Sec. Analytical Chemistry Volume 12 - 2024 | <nowiki>https://doi.org/10.3389/fchem.2024.1433626</nowiki>

===2020 [https://www.sciencedirect.com/science/article/abs/pii/S0946672X2030167X?via%3Dihub Association of electronic cigarette use with lead, cadmium, barium, and antimony body burden: NHANES 2015-2016]===

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*[https://sci-hub.se/10.1016/j.yrtph.2016.10.003 PDF Version]

*Citation: Ana S. Cravo, Jim Bush, Girish Sharma, Rebecca Savioz, Claire Martin, Simon Craige, Tanvir Walele, A randomised, parallel group study to evaluate the safety profile of an electronic vapour product over 12 weeks, Regulatory Toxicology and Pharmacology, Volume 81, Supplement 1, 2016, Pages S1-S14, ISSN 0273-2300, doi: 10.1016/j.yrtph.2016.10.003.

*Acknowledgement: This work was funded and supported by Fontem Ventures B.V. Imperial Brands plc is the parent company of Fontem Ventures B.V., the manufacturer of the EVP prototype used in this study.

===2016 [https://academic.oup.com/ntr/article-abstract/19/2/160/2631650?redirectedFrom=fulltext Exposure to Nicotine and Selected Toxicants in Cigarette Smokers Who Switched to Electronic Cigarettes: A Longitudinal Within-Subjects Observational Study]===

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*Smokers using [[Special:MyLanguage/Abbreviations|EC]]s over 4 weeks maintained cotinine levels and experienced significant reductions in carbon monoxide, [[Special:MyLanguage/Abbreviations|NNAL]], and two out of eight measured [[Special:MyLanguage/Abbreviations|VOC]] metabolites. Those who switched exclusively to ECs for at least half of the study period significantly reduced two additional VOCs.

*[https://sci-hub.se/10.1093/ntr/ntw333 PDF Version]

*Citation: Pulvers, K., Emami, A. S., Nollen, N. L., Romero, D. R., Strong, D. R., Benowitz, N. L., & Ahluwalia, J. S. (2016). Tobacco Consumption and Toxicant Exposure of Cigarette Smokers Using Electronic Cigarettes. Nicotine & Tobacco Research, ntw333. doi:10.1093/ntr/ntw333

*Acknowledgement: This study was funded by the University of Minnesota (JA), P30 DA012393 (NB), P50 CA180890 (NB), and California State University San Marcos (KP).

===2016 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4940751/ Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes]===

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*[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4940751/pdf/12889_2016_Article_3236.pdf PDF Version]

*Citation: D'Ruiz CD, Graff DW, Robinson E. Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes. BMC Public Health. 2016 Jul 11;16:543. doi: 10.1186/s12889-016-3236-1. PMID: 27401980; PMCID: PMC4940751.

*Acknowledgement: This study was funded by Fontem Ventures B.V., a fully owned subsidiary of Imperial Brands plc, and the manufacturer of the e-cigarette products used in this study.

===2016 [https://www.sciencedirect.com/science/article/pii/S1383571816301711?via%3Dihub The mutagenic assessment of an electronic-cigarette and reference cigarette smoke using the Ames assay in strains TA98 and TA100]===

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*Under the conditions tested, Vype ePen e-cigarette aerosol was significantly less cytotoxic than reference 3R4F cigarette smoke.

*[https://sci-hub.se/10.1080/15376516.2016.1217112 PDF Version]

*Citation: Azzopardi, D., Patel, K., Jaunky, T., Santopietro, S., Camacho, O. M., McAughey, J., & Gaça, M. (2016). Electronic cigarette aerosol induces significantly less cytotoxicity than tobacco smoke. Toxicology Mechanisms and Methods, 26(6), 477–491. doi:10.1080/15376516.2016.1217112

*Acknowledgement: This study was funded by BAT. The authors are employees of British American Tobacco (BAT). Nicoventures Ltd., UK, is a wholly-owned subsidiary of British American Tobacco.

===2015 [https://www.sciencedirect.com/science/article/pii/S0887233315001228?via%3Dihub Development of an in vitro cytotoxicity model for aerosol exposure using 3D reconstructed human airway tissue; application for assessment of e-cigarette aerosol]===

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*Mainstream cigarette smoke HPHCs (∼3000 μg/puff) were 1500 times higher than e-cigarette HPHCs.

*No significant contribution of tested HPHC classes was found for the e-cigarettes.

*[https://sci-hub.se/10.1016/j.yrtph.2014.10.010 PDF Version]

*Citation: Tayyarah, R., & Long, G. A. (2014). Comparison of select analytes in aerosol from e-cigarettes with smoke from conventional cigarettes and with ambient air. Regulatory Toxicology and Pharmacology, 70(3), 704–710. doi:10.1016/j.yrtph.2014.10.010

*Acknowledgements: The company for which the study authors work and the companies that manufacture the e-cigarettes tested for this study are owned by the same parent company (Lorillard Tobacco Company)

===2014 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110871/ Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review]===

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*[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110871/pdf/10.1177_2042098614524430.pdf PDF Version]

*Citation: Farsalinos KE, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Ther Adv Drug Saf. 2014 Apr;5(2):67-86. doi: 10.1177/2042098614524430. PMID: 25083263; PMCID: PMC4110871.

*Acknowledegement: Riccardo Polosa is a Professor of Medicine and is supported by the University of Catania, Italy. He has received lecture fees and research funding from GlaxoSmithKline and Pfizer, manufacturers of stop smoking medications. He has also served as a consultant for Pfizer and Arbi Group Srl (Milano, Italy), the distributor of Categoria™ e-Cigarettes. His research on electronic cigarettes is currently supported by LIAF (Lega Italiana AntiFumo).

*Acknowledgement: Konstantinos Farsalinos is a researcher at Onassis Cardiac Surgery Center. He has never been funded by the pharmaceutical or the tobacco industry. For some of his studies, the institution has received financial compensation from electronic cigarette companies for the studies’ cost. His salary is currently being paid by a scholarship grant from the Hellenic Society of Cardiology.

===2014 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4154473/ Levels of selected carcinogens and toxicants in vapor from electronic cigarettes]===

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*This study indicates that EC vapor is significantly less cytotoxic compared to tobacco CS.

*[https://sci-hub.se/10.3109/08958378.2013.793439 PDF Version]

*Citation: Romagna, G., Allifranchini, E., Bocchietto, E., Todeschi, S., Esposito, M., & Farsalinos, K. E. (2013). Cytotoxicity evaluation of electronic cigarette vapor extract on cultured mammalian fibroblasts (ClearStream-LIFE): comparison with tobacco cigarette smoke extract. Inhalation Toxicology, 25(6), 354–361. doi:10.3109/08958378.2013.793439

*Acknowledgement: The study was funded by FlavourArt s.r.l. No author has received any financial compensation for this study. The study was investigator-initiated and investigator-driven. The sponsor had no involvement in the study design, data collection, analysis and interpretation, writing or approving the manuscript and decision to submit the manuscript for publication.

*Keywords: Cytotoxicity, electronic cigarette, fibroblasts, in vitro, nicotine, smoking, tobacco harm reduction

=ENDS (without comparison to other products)=

@@ Line 11: / Line 11: @@
 =ENDS vs Smoking Tobacco, Heated Tobacco Product/Heat not Burn, or Nicotine Replacement Therapy= <!--T:2-->
+=== 2024 [https://www.frontiersin.org/journals/chemistry/articles/10.3389/fchem.2024.1433626/full Analytical methods and experimental quality in studies targeting carbonyls in electronic cigarette aerosols] ===
+* This review highlights the necessity to evaluate the quality of laboratory standards in testing EC emissions to achieve an objective assessment of the risk profile of ECs.
+* Since the presence of carbonyl by-products in EC aerosol is concerning, it is important to evaluate the reliability of emission studies quantifying these compounds by verifying their compliance with the following criteria of experimental quality: authors must 1) supply sufficient information on the devices and experimental procedures to allow for potentially reproducing or replicating the experiments, 2) use of appropriate puffing protocols that approach consumer usage as best as possible, 3) use of appropriate analytical methods and 4) usage of blank samples to avoid false positive detection.
+* However, the studies exhibited the following experimental flaws:
+** Although only five of the 14 studies used blank samples, alternative validation methods have been employed.
+** six studies failed the replicability condition by not disclosing sufficient information on the devices and experimental procedures.
+* The issues listed above are serious methodological flaws that occur also in many emission studies.
+* TL/DR There is a lot that needs to be improved to ensure studies accurately reflect real usage conditions.
+* Sussman RA, Sipala FM, Ronsisvalle S and Soulet S, Front. Chem., 09 August 2024 Sec. Analytical Chemistry Volume 12 - 2024 | <nowiki>https://doi.org/10.3389/fchem.2024.1433626</nowiki>
 ===2020 [https://www.sciencedirect.com/science/article/abs/pii/S0946672X2030167X?via%3Dihub Association of electronic cigarette use with lead, cadmium, barium, and antimony body burden: NHANES 2015-2016]=== <!--T:3-->
@@ Line 199: / Line 208: @@
 *[https://sci-hub.se/10.1016/j.yrtph.2016.10.003 PDF Version]
 *Citation: Ana S. Cravo, Jim Bush, Girish Sharma, Rebecca Savioz, Claire Martin, Simon Craige, Tanvir Walele, A randomised, parallel group study to evaluate the safety profile of an electronic vapour product over 12 weeks, Regulatory Toxicology and Pharmacology, Volume 81, Supplement 1, 2016, Pages S1-S14, ISSN 0273-2300, doi: 10.1016/j.yrtph.2016.10.003.
-*Acknowledgement: This work was funded and supported by Fontem Ventures B.V. Imperial Brands plc is the parent company of Fontem Ventures B.V., the manufacturer of the EVP prototype used in this study.
 ===2016 [https://academic.oup.com/ntr/article-abstract/19/2/160/2631650?redirectedFrom=fulltext Exposure to Nicotine and Selected Toxicants in Cigarette Smokers Who Switched to Electronic Cigarettes: A Longitudinal Within-Subjects Observational Study]=== <!--T:39-->
@@ Line 220: / Line 226: @@
 *Smokers using [[Special:MyLanguage/Abbreviations|EC]]s over 4 weeks maintained cotinine levels and experienced significant reductions in carbon monoxide, [[Special:MyLanguage/Abbreviations|NNAL]], and two out of eight measured [[Special:MyLanguage/Abbreviations|VOC]] metabolites. Those who switched exclusively to ECs for at least half of the study period significantly reduced two additional VOCs.
 *[https://sci-hub.se/10.1093/ntr/ntw333 PDF Version]
 *Citation: Pulvers, K., Emami, A. S., Nollen, N. L., Romero, D. R., Strong, D. R., Benowitz, N. L., & Ahluwalia, J. S. (2016). Tobacco Consumption and Toxicant Exposure of Cigarette Smokers Using Electronic Cigarettes. Nicotine & Tobacco Research, ntw333. doi:10.1093/ntr/ntw333
-*Acknowledgement: This study was funded by the University of Minnesota (JA), P30 DA012393 (NB), P50 CA180890 (NB), and California State University San Marcos (KP).
 ===2016 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4940751/ Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes]===
@@ Line 234: / Line 237: @@
 *[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4940751/pdf/12889_2016_Article_3236.pdf PDF Version]
 *Citation: D'Ruiz CD, Graff DW, Robinson E. Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes. BMC Public Health. 2016 Jul 11;16:543. doi: 10.1186/s12889-016-3236-1. PMID: 27401980; PMCID: PMC4940751.
-*Acknowledgement: This study was funded by Fontem Ventures B.V., a fully owned subsidiary of Imperial Brands plc, and the manufacturer of the e-cigarette products used in this study.
 ===2016 [https://www.sciencedirect.com/science/article/pii/S1383571816301711?via%3Dihub The mutagenic assessment of an electronic-cigarette and reference cigarette smoke using the Ames assay in strains TA98 and TA100]=== <!--T:45-->
@@ Line 252: / Line 254: @@
 *Under the conditions tested, Vype ePen e-cigarette aerosol was significantly less cytotoxic than reference 3R4F cigarette smoke.
 *[https://sci-hub.se/10.1080/15376516.2016.1217112 PDF Version]
 *Citation: Azzopardi, D., Patel, K., Jaunky, T., Santopietro, S., Camacho, O. M., McAughey, J., & Gaça, M. (2016). Electronic cigarette aerosol induces significantly less cytotoxicity than tobacco smoke. Toxicology Mechanisms and Methods, 26(6), 477–491. doi:10.1080/15376516.2016.1217112
-*Acknowledgement: This study was funded by BAT. The authors are employees of British American Tobacco (BAT). Nicoventures Ltd., UK, is a wholly-owned subsidiary of British American Tobacco.
 ===2015 [https://www.sciencedirect.com/science/article/pii/S0887233315001228?via%3Dihub Development of an in vitro cytotoxicity model for aerosol exposure using 3D reconstructed human airway tissue; application for assessment of e-cigarette aerosol]=== <!--T:49-->
@@ Line 273: / Line 272: @@
 <!--T:52-->
+*Mainstream cigarette smoke HPHCs (∼3000 μg/puff) were 1500 times higher than e-cigarette HPHCs.
 *No significant contribution of tested HPHC classes was found for the e-cigarettes.
 *[https://sci-hub.se/10.1016/j.yrtph.2014.10.010 PDF Version]
 *Citation: Tayyarah, R., & Long, G. A. (2014). Comparison of select analytes in aerosol from e-cigarettes with smoke from conventional cigarettes and with ambient air. Regulatory Toxicology and Pharmacology, 70(3), 704–710. doi:10.1016/j.yrtph.2014.10.010
-*Acknowledgements: The company for which the study authors work and the companies that manufacture the e-cigarettes tested for this study are owned by the same parent company (Lorillard Tobacco Company)
 ===2014 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110871/ Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review]=== <!--T:53-->
@@ Line 287: / Line 284: @@
 *[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110871/pdf/10.1177_2042098614524430.pdf PDF Version]
 *Citation: Farsalinos KE, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Ther Adv Drug Saf. 2014 Apr;5(2):67-86. doi: 10.1177/2042098614524430. PMID: 25083263; PMCID: PMC4110871.
-*Acknowledegement: Riccardo Polosa is a Professor of Medicine and is supported by the University of Catania, Italy. He has received lecture fees and research funding from GlaxoSmithKline and Pfizer, manufacturers of stop smoking medications. He has also served as a consultant for Pfizer and Arbi Group Srl (Milano, Italy), the distributor of Categoria™ e-Cigarettes. His research on electronic cigarettes is currently supported by LIAF (Lega Italiana AntiFumo).
-*Acknowledgement: Konstantinos Farsalinos is a researcher at Onassis Cardiac Surgery Center. He has never been funded by the pharmaceutical or the tobacco industry. For some of his studies, the institution has received financial compensation from electronic cigarette companies for the studies’ cost. His salary is currently being paid by a scholarship grant from the Hellenic Society of Cardiology.
 ===2014 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4154473/ Levels of selected carcinogens and toxicants in vapor from electronic cigarettes]=== <!--T:55-->
@@ Line 319: / Line 312: @@
 *This study indicates that EC vapor is significantly less cytotoxic compared to tobacco CS.
 *[https://sci-hub.se/10.3109/08958378.2013.793439 PDF Version]
 *Citation: Romagna, G., Allifranchini, E., Bocchietto, E., Todeschi, S., Esposito, M., & Farsalinos, K. E. (2013). Cytotoxicity evaluation of electronic cigarette vapor extract on cultured mammalian fibroblasts (ClearStream-LIFE): comparison with tobacco cigarette smoke extract. Inhalation Toxicology, 25(6), 354–361. doi:10.3109/08958378.2013.793439
-*Acknowledgement: The study was funded by FlavourArt s.r.l. No author has received any financial compensation for this study. The study was investigator-initiated and investigator-driven. The sponsor had no involvement in the study design, data collection, analysis and interpretation, writing or approving the manuscript and decision to submit the manuscript for publication.
-*Keywords: Cytotoxicity, electronic cigarette, fibroblasts, in vitro, nicotine, smoking, tobacco harm reduction
 =ENDS (without comparison to other products)= <!--T:61-->